Unknown statusPhase 2

Ayahuasca Assisted Psychotherapy for Grief

NCT06150859 · PSICODUELAYA · Beckley Med Foundation

Closed to entry

Status

Not accepting participants

Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

The aim of this study is to compare the effectiveness of an ayahuasca-assisted constructivist therapy with constructivist therapy and no treatment to decrease the severity of grief. A secondary purpose is to assess the effectiveness to prevent Persistent Complex Bereavement Disorder and Prolonged Grief Disorder, and to assess potential changes in avoidance, meaning-making and self-clarity. Subjective effects and Acceptance promoting effects of psychedelic drug are assessed after ayahuasca administration. A non-randomized controlled trial is proposed with three arms involving an experimental group (ayahuasca in concert with psychotherapy) and two control groups (psychotherapy and no treatment) with pretest, posttest and 3 months follow-up.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in the severity of grief symptoms
Measured over Time Frame: Baseline to End of Intervention, up to 3 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Experienced the loss of a first- degree relative not more than 12 months prior to enrollment as indicated by self-report. * Scores up to 40 in the Texas Revised Inventory of Grief (TRIG). Exclusion Criteria: * Pregnant or breastfeeding women. * Hypertension (systolic blood pressure above 140 mm, diastolic above 90 mm and heart rate above 100 bpm). * History of psychotic disorder (Axis I-II of the DSM-V). * Substance use disorder (except nicotine). * Alcohol consumption greater than 40 g/day. * Receiving psychological or self-help therapy during the study on a regular basis. * Receiving regular pharmacological therapy for complicated grief during the study. * Regular intake of any type of medication in the month preceding the study. * Treatment with single doses of symptomatic medication during the study may be accepted (as long as it can be assumed that the ingested drug has been completely eliminated on the days of the ayahuasca administrations).

Where

1 study site

Facility	City	Region	Country
Institut de Recerca Holistica de Montserat (Irehom)	Barcelona	—	Spain

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06150859 on ClinicalTrials.gov →

Last updated in the registry 2023-12-11. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance